Canadian clinical trial registry

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Study Description

(from https://forpatients.roche.com/en/trials/cancer/solid-tumors/tumor-agnostic-precision-immuno-oncology-and-somatic-ta-50851.html)

This clinical trial is recruiting people who have advanced solid tumors that cannot be surgically removed. You (or your child) must have had genetic testing on the solid tumors that shows a positive result for one of the genetic changes, also known as biomarkers, being tested in this trial.

The purpose of this clinical trial is to compare the effects, good or bad, of different targeted therapies and immunotherapies in patients with solid tumors that cannot be surgically removed and show specific biomarkers.

To be able to take part in this clinical trial, you (or your child) must have been diagnosed with solid tumors that cannot be surgically removed and show one of the specific biomarkers that are being tested in this study:

• ROS1 fusion-positive tumors
• NTRK1/2/3 fusion-positive tumors
• TMB-high tumors
• ALK fusion-positive
• AKT1/2/3 mutant-positive tumors
• HER2 mutant-positive tumors
• PIK3CA multiple mutant-positive tumors
• BRAF class II mutant or fusion-positive tumors
• BRAF class III mutant-positive tumors
• RET fusion-positive tumors

Your doctor will be able to give you more information on the type of biomarker your solid tumors show. You must be otherwise in good health to take part. You will not be able to take part if you are pregnant or breastfeeding, or if you have received any recent treatment for your cancer. Some of the groups may have other specific requirements. Your doctor will be able to give you more information on this.

Inclusion Criteria

• Less than 18 years of age for cohort E and K
• Age between 12 and 17 years for cohorts E, F and H
• Diagnosis of advanced cancer that has spread to a different part of the body (metastasized) and can’t be removed by an operation (unresectable)
• Participants must be up and about at least 50% of their waking hours
• The cancer must have a specific genetic change in one of the following genes: ROS1, NTRK1/2/3, AKT, PIK3CA, HER2, BRAF, RET, or be TMB-high

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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Study Description

This study seeks to test the effectiveness and best dosage for 2 different combinations of drugs in treating cancers that have come back (recurring) or never completely went away (refractory) after initial treatment. Participants will be randomly assigned to either Arm A or Arm B of the study which will determine the combination of drugs they receive.

In Arm A, participants will receive drugs called Onivyde and talazoparib.

In Arm B, participants will receive drugs called Onivyde and temozolomide.

Both combination of drugs (Onivyde + talazoparib or Onivyde + temozolomide) are expected to irreparably damage the DNA in cancer cells and lead to cancer cell death.

After the best dosages of the drug combinations are determined in Arm A and Arm B, then the study will move on to the next stage called “expansion arms”. These expansion arms treat more participants with the dosages determined in the earlier Arm A and Arm B.

There are 3 expansion arms in this study:

Arm A1: Participants with Ewing sarcoma that has come back (recurring) or never completely went away (refractory) will receive drugs called Onivyde and talazoparib.

Arm A2: Participants with cancers that have come back (recurring) or never completely went away (refractory), and their cancer has a problem with repairing DNA (identified by their doctor) will receive drugs called Onivyde and talozoparib.

Arm B1: Participants with cancers that have come back (recurring) or never completely went away (refractory) will receive drugs called Onivyde and temozolomide.

Inclusion Criteria

• Participants must be > 12 months and <30 years at the time of enrollment
• Diagnosed with cancers that have come back (recurring) or never completely went away (refractory)

• Female or male participant of reproductive potential must agree to use effective contraceptive methods at screening and throughout duration of study treatment.
• Female participants who have begun to menstruate must have a negative urine or serum pregnancy test and must be willing to have additional serum and urine pregnancy tests during the study
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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Study Description

This is a phase I/II trial that studies how well the treatments tiragolumab and atezolizumab work when given to children with tumours that have either come back (relapsed) or did not respond to therapy (refractory). These tumours must have a certain mutation, meaning the cancer cells are missing important genes called SMARCB1 and SMARCA4. Tiragolumab and atezolizumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Inclusion Criteria

• Participants must be between 1-18 years old for part A of this study. There is no upper age limit for part B
• Participants must have one of the following cancers, that has either come back (relapsed) or did not respond to previous treatment (refractory):
  • Renal medullary carcinoma
  • Malignant rhabdoid tumor (extra-CNS)
  • Atypical teratoid rhabdoid tumor (CNS)
  • Poorly differentiated chordoma
  • Epithelioid sarcoma
• Cancer must have the eligible mutation (SMARCB1 or SMARCA4)
• Participants must be up and about for at least half their waking hours
• Participants must meet all bloodwork criteria outlined for this study

Other inclusion and exclusion criteria may apply and will be discussed with you by your clinical team

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Study Description

This is a phase 3 study for patients with newly diagnosed diffuse glioma. To be eligible for this study, the participant's cancer must have a mutation called H3 K27M. This study explores whether adding treatment with the experimental drug called ONC201 after radiotherapy is effective in patients with this type of cancer. 

Inclusion Criteria

• Able to understand the study procedures and agree to participate in the study by providing written informed consent and assent when applicable.
• Body weight ≥ 10 kg
• A new diagnosis of diffuse glioma with a H3 K27M mutation 
• Received frontline radiotherapy (radiation) within 2-6 weeks of starting this study
• Patient must be capable of self-care but may be unable to engage in normal activities or perform active work

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.

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Study Description

Testing the Combination of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) in Children, Adolescent, and Young Adult Patients With Relapsed/Refractory Cancers That Have an Increased Number of Genetic Changes, The 3CI Study

This study investigates the side effects of the combination of two immunotherapy medications called nivolumab and ipilimumab, and to see how well they work in treating children, adolescents and young adults with cancers that have come back (relapsed) or does not respond to treatment (refractory) and have an increased number of genetic changes. Immunotherapy with nivolumab and ipilimumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

This study is being done to help doctors learn if the combination of nivolumab and ipilimumab can help children, adolescents, and young adults patients live longer.

This study will have two parts

• PART I: A tissue sample from the tumour is analysed for "tumour mutation burden" level. Patients with elevated level may be eligible for Part II.
• PART II: Patients receive receive treatment with nivolumab or nivolumab and ipilimumab.

Inclusion Criteria

• Age from 12 months to 25 years
• Patient with a cancer that has come back (relapsed) or does not respond to treatment (refractory)
• All tumours can be considered except leukemia and diffuse intrinsic pontine glioma
• The tumour will be tested (part 1). It needs to to have an increased number of genetic changes for the patient to be considered for part 2
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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Study Description

A clinical trial to look at how safe and tolerable the drug RO7428731 is at different doses, how the body processes it, and if there are any early signs of treatment efficacy of RO7428731 in patients with glioblastoma that has the marker EGFRvIII

Via: Clinical Trial – Glioblastoma – Safety, Tolerability, Pharm... (roche.com)

Inclusion Criteria

• Diagnosis of glioblastoma with a tumour expression called EGFRvIII
• Must have completed standard of care therapy prior to joining this study
• Must be up and about at least 70% of their waking hours
• Adequate organ functions prior to start of study treatment
• Willingness to abide by contraceptive measures for the duration of the study.

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team

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Study Description

This study is to investigate how effective and safe the use of SPEAR™ T cells is in patients with Synovial Sarcoma or Myxoid/Round Cell Liposarcoma.

Inclusion Criteria

• Age ≥16 (10 years at selected sites) and <=75 years
• Diagnosis of advanced synovial sarcoma or myxoid liposarcoma / myxoid round cell liposarcoma with the appropriate genetic marker
• Measurable disease
• Adequate performance status (patient's level of functioning) 

Note: other protocol defined Inclusion criteria may apply and will be discussed with you by the study team.

Publications

A kinase-cGAS cascade to synthesize a therapeutic STING activator - PubMed (nih.gov)

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Study Description

The purpose of this study is to test the safety of an investigational drug called CFI-400945 alone and in combination with azacitidine.

Inclusion Criteria

• Patients must be >18 years of age
• Patients must have a qualifying diagnosis of Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) that has come back or not responded to other treatment
• Have acceptable laboratory screening results within certain limits
• Be able to carry out light daily work with little/no restriction

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team